Unproven stem cell clinics are facing a variety of lawsuits these days including two prominent cases filed by the FDA. There are widespread patient suits against clinics as well. In April we saw a new kind of suit in the form of the NY State Attorney General (AG) Letitia James filingagainst a Manhattan clinic.

I’m not going to rehash the allegations (see the above link to my piece with more info), but this one quote from the AG office has some key details: “Attorney General Letitia James today announced a lawsuit filed against Park Avenue Stem Cell, a New York City for-profit stem cell clinic, and its managing doctor, Dr. Joel B. Singer, M.D., for allegedly engaging in fraudulent and illegal advertising regarding its stem cell procedures.”

Singer’s attorney in this case is Richard Jaffe. He may be most well known overall for having been the attorney for Stanislaw Burzynski, although he’s getting more well known for representing stem cell clinics. Jaffe recently blogged about the defendant’s response to the NY AG here and included a link to their answer/counter-claim document here.

The response is creative, but in my opinion the main thrusts are not very strong. As I often do with legal matters, I am including a disclaimer here that I’m not an attorney. So in this kind of situation I’m approaching the filings as a stem cell scientist and via common sense as I see it. Others are likely to disagree.

In this post I dissect a couple of what I see as the defense’s main points.

Everybody’s doing it?

The NY stem cell clinic’s reply starts with this in bold letters, “The Context of this Case: Stem Cell Transplantation is the Cutting-Edge Standard of Care in the United States, as is the Dissemination of Information and Advocacy for these Procedures.”

Right away I’m thinking to myself, “Nope.”

Unfortunately, we are not to the point where stem cell transplantation is a standard of care for anything other than using bone marrow or umbilical cord-related products for a few very specific things related to blood disorders and cancers. As best as I can tell, this NY stem cell clinic is not doing that kind of stuff. Instead, they are often using fat stem cells and maybe sometimes other materials for a variety of health issues. For me as a stem cell biologist, that’s not a “standard” area of medicine. I hope that maybe in a decade fat stem cells will be approved as a safe and effective approach for specific uses based on hard science, but we’re not there.

To try to further support their notion of their offerings being “standard” approaches, the filing also says, “However, missing from the complaint is the fact that many of the country’s leading medical institutions, as well as hundreds of other cutting-edge medical clinics across the nation, are using the same procedure as the Defendants.”

The same procedure? Actually, no, at least not when it comes to the leading medical institutions I know of in this area of medicine, and I don’t consider stem cell clinics to fall under that umbrella term.

While a number of universities and medical centers perhaps constituting some of the “leading medical institutions” are offering in a broad sense “regenerative medicine” injections, these are almost entirely involving just a few narrow types of things not including fat stem cells. Instead, what is commonly offered at various non-stem cell clinic providers are bone marrow-related products and platelet rich plasma (PRP). Also, just because some institutions like Swedish in Seattle are offering certain regenerative medicine procedures, doesn’t mean that they are proven to work or be safe. Some of the regenerative medicine marketing by big institutions is also problematic. You can see my concerns about some claims from Swedish here. Note that by “offering” here I mean using in the clinic as though it is known to work, not just studying it in a clinical trial.

Right to privacy (in use of product derived from the body)?

What else does the defense argue? A privacy right. See this section, which was bolded in their response: “New York Patients Have The New York Constitutional And Privacy Rights To Utilize Their Own Body Parts For Treatment And The First Amendment Rights To Receive All Available Information About These Medical Procedures Without The Government Filtering Content Based On The Plaintiff’s Asserted Position That Patients Are Not Sufficiently Intelligent To Comprehend The Meaning Of The Content On Defendants Website.”

I’m not so sure about these arguments.

First of all, my understanding is that once a person’s cells are removed from their body and especially after a firm turns them into a distinct drug product like stromal vascular fraction (SVF) made from fat, that new product is no longer part of the person any more and there is no privacy right to that. Again, I’m no lawyer so I could be wrong about this technically, but I’m just focusing again on my impressions and views. I am not familiar with the New York State constitution so I can’t really comment on that claim of some “right” there for clinic customers related to that state constitution specifically. Anyone know?

First Amendment relevance?

The second part of the above quote, on the First Amendment coming into play, also seems like a stretch to me. The clinic website appears to me to more be advertising its services than educating patients. However, admittedly, the area where First Amendment rights and advertising overlap seems complex. The defense response argues that consumers have a First Amendment right to receive information from the stem cell clinic. Again a lot seems to boil down to whether the website is doing medical advertising subject to FTC and/or FDA oversight, or instead just consists of educational materials.

A look at the clinic website shapes my opinion that the site is mainly focused on marketing, and their blog especially supports this idea. For instance on the blog, I see statements about muscular dystrophy, “Get some clues and information about this condition and how personal cell therapy can help by calling Park Avenue Stem Cell”, about neuropathy, “Find out more about this condition and how to manage it with personal cell therapy by calling Park Avenue Stem Cell today”, about arthritis, “Call Park Avenue Stem Cell for more information about the power of personal cells for arthritis”, and “Learn how personal stem cells may benefit men and women living with Alzheimer’s disease.”

The list goes on and on of what seem to me to be marketing claims and inducements to become a customer. In my view some of them are particularly worrisome such as the notion that stem cells should be used now to treat Alzheimer’s, and the claims generally are not supported by strong clinical trial data.

I disagree again. Aspirin (a drug) does not contain living cells either. SVF can be extracted by non enzymatic means as well. And, similar to PRP, nothing is being made or created; only extracted .(In my non scientific, stem cell, populist opinion). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5055005/